Pretoria pharmacy's troubles compound as Novo Nordisk takes legal action
A Pretoria pharmacy, which was the subject of a recent weight-loss drug crackdown in South Africa, is once again making headlines as the Danish pharmaceutical company Novo Nordisk takes it to the High Court.
The logo of pharmaceutical company Novo Nordisk is displayed in front of its offices in Bagsvaerd, Copenhagen, Denmark. Image credit: Reuters/Tom Little/File Photo
Reuters states that Novo Nordisk South Africa filed a High Court application seeking to prevent local compounding pharmacy iDexis from manufacturing, advertising, distributing and selling "unregistered and untested" weight-loss products containing semaglutide base, the key ingredient in its Wegovy and Ozempic, pending the court's consideration of the matter.
Safety concerns
"Our concerns relate to patient safety, product quality and regulatory oversight," Novo said in a statement.
Compounding, the practice of mixing or altering drug ingredients for individual patients, is tightly restricted in South Africa and not permitted for large-scale manufacturing or sale of unregistered medicines — a legal boundary central to the case underway in the High Court in Pretoria.
iDexis, trading as Sentra Pharmacy in Silverton, Pretoria, states its active pharmaceutical ingredients are sourced from reputable, internationally approved manufacturers and tested in independent laboratories for sterility and quality.
It has rejected Novo's claims as "scandalous" and unsubstantiated, and has asked the court to compel the company to produce evidence supporting its allegations, according to court filings seen by Reuters
Novo's legal action reflects a broader push by drugmakers to curb compounded versions of GLP-1 drugs. In the United States, Novo has taken action against pharmacies and telehealth platforms offering copies of semaglutide, arguing they circumvent regulatory safeguards and pose safety risks.
GLP-1 drugs, widely used for diabetes and weight loss, saw demand surge in South Africa last year following the launch of Eli Lilly's blockbuster Mounjaro and subsequently Novo's Wegovy.
The cost for the lowest injected dose of Wegovy has dropped from R3,090 to R1,873, while the cost of the highest dose has fallen 27% to 3,746 rand.
Outright ban
Unable to afford the drugs, some patients switched to compounded copies of the medication, opening up a grey market for many pharmacies and local producers.
Despite safety assurances, MedicalBrief reports that the Pharmaceutical Task Group (PTG), which represents over 80% of South Africa’s pharmaceutical industry, has been calling on the country's health regulators to follow the lead of leading global regulators and completely ban GLP-1 compounding by pharmacists.
A joint inspection by the South African Health Products Regulatory Authority and the South African Pharmacy Council found iDexis was producing GLP-1 medicines, including tirzepatide, for broader commercial distribution — beyond what regulations allow.
Inspectors cited serious deficiencies in quality, safety and compliance. Authorities seized products and ordered a recall of medicines distributed via healthcare providers and pharmacies.
"Unlawful manufacturing, promotion and distribution of unregistered GLP-1 medicines for weight loss is a serious violation of the law and a direct threat to public safety," Vincent Tlala, CEO of the SAPC, said.